BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT M2 CUSHION

    MDR report key: 24029823 · Received January 9, 2026

    Report

    Report Number
    2135139-2025-00004
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 10, 2025
    Report Date
    January 9, 2026
    Manufacturer
    THE COMFORT COMPANIES, L.L.C.
    Product Code
    KNO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED ON USE HISTORY SO UNKNOWN IF FAILURE DUE TO NORMAL USE OR REASONABLY FORESEEABLE MISUSE.

    Description of Event or Problem · 0

    THE CUSTOMER STATED, "THE BACK SIDE OF THE CUSHION IS FLAT AND NOW CAUSING SACRAL WOUNDS". THE USER IS AN 83-YEAR-OLD FEMALE, WEIGHING 149 LBS. AND STANDING 64 INCHES TALL. THE CHAIR IN USE WAS A KI MOBILITY ULTRALIGHT MANUAL WHEELCHAIR. THE CUSTOMER REPORTED NORMAL USAGE OF THE PRODUCT. THE CUSHION HAD BEGUN TO CAUSE SKIN BREAKDOWN; HOWEVER, NO SIGNIFICANT MEDICAL INTERVENTION WAS REQUIRED. UPON INSPECTING THE RETURNED PRODUCT, A GEL LEAK WAS OBSERVED IN TWO SEPARATE AREAS; HOWEVER, IT WAS ALSO NOTED THAT THE GEL PACK APPEARED THINNER THAN EXPECTED AND CONTAINED MINIMAL GEL. WHEN PRESSING ON DIFFERENT QUADRANTS OF THE GEL PACK, THEY FELT NEARLY EMPTY EVEN THOUGH 2 OF THEM DID NOT HAVE A VISUAL LEAK. SINCE THE AMOUNT OF GEL THAT VISIBLY LEAKED WAS MINIMAL COMPARED TO PREVIOUS GEL LEAK INCIDENTS, THE GEL LEAK MAY HAVE OCCURRED AFTER THE GEL PACK LIQUID ALREADY SIGNIFICANTLY DEHYDRATED. BASED ON THE INFORMATION IN THE RMA AND THE INSPECTION OF THE RETURNED PRODUCT, THE ROOT CAUSE IS MOST LIKELY DUE TO GEL DEHYDRATION. ALTHOUGH THE GEL PACK LEAKED, THE MINIMAL AMOUNT OF GEL PRESENT INDICATES THAT DEHYDRATION HAD OCCURRED BEFOREHAND. WHEN GEL PACKS LEAK OR DEHYDRATE, THEIR LIQUID VOLUME DECREASES, WHICH DECREASES THE TOTAL VOLUME IN THE SEATING AREA. SINCE THE GEL PACK IS SANDWICHED BETWEEN FOAM LAYERS (FIRMER MOLDED BASE FOAM WITH SOFTER TOPPER FOAM) AND IT IS BONDED TO THOSE LAYERS WITH AN ADHESIVE, THIS CAUSES THE SOFTER TOPPER FOAM LAYER TO SINK, GIVING THE APPEARANCE OF FLATTENING. THE DEHYDRATED GEL WAS NOT HARD, BUT IT DID DECREASE THE OVERALL THICKNESS OF THE CUSHION, WHICH MAY HAVE CAUSED THE CUSHION TO BOTTOM OUT DURING USE, BUT THAT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88015 COMFORT M2 CUSHION COMFORT M2 CUSHION KNO THE COMFORT COMPANIES, L.L.C. M2-F-1819

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown Other